Trial Outcomes & Findings for Fludarabine Phosphate, Radiation Therapy, and Rituximab in Treating Patients Who Are Undergoing Donor Stem Cell Transplant Followed by Rituximab for High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT00104858)
NCT ID: NCT00104858
Last Updated: 2019-07-11
Results Overview
Number of participants surviving post-transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
At 18 months
Results posted on
2019-07-11
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine Phosphate, Radiation Therapy, and Rituximab in Treating Patients Who Are Undergoing Donor Stem Cell Transplant Followed by Rituximab for High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment
n=52 Participants
Patients receive fludarabine intravenously (IV) on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose total-body irradiation (TBI) on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation (HSCT) on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine orally (PO) twice daily (BID) on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or three times daily (TID) on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
|
Age, Continuous
|
59.5 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=39 Participants
|
|
Region of Enrollment
Denmark
|
7 participants
n=39 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At 18 monthsPopulation: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Number of participants surviving post-transplant
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Overall Survival
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Lack of funds to support sample collection analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 84Population: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Relapse/Progression criteria for CLL Progressive disease: ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. Relapsed disease: Criteria of progression occurring 6 months after achievement of complete or partial remission.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Number of Participants With Relapse/Progression
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 84Population: Lack of funds to support sample collection and analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Number of patients who developed acute GVHD post-transplant. Grade I +1 to +2 skin rash, No gut or liver involvement Grade II +1 to +3 skin rash, +1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or +2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD
|
46 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the first 100 daysPopulation: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Reported using the adapted National Cancer Institute Common Toxicity Criteria.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Number of Participants With Regimen-related Toxicity and Infections
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Number of subjects expired without disease progression/relapse.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Number of Participants With Treatment-related Mortality
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 60, 84, 180, and 1 yearPopulation: Number of participants varies by interval based on the number of samples received.14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Median rituxan level at days 60, 84, 180, and 1 year.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Rituxan Concentration
Day 60
|
109 ug/ml
Interval 0.2 to 480.5
|
—
|
|
Rituxan Concentration
Day 84
|
51 ug/ml
Interval 0.1 to 369.0
|
—
|
|
Rituxan Concentration
Day 180
|
1.3 ug/ml
Interval 0.0 to 103.6
|
—
|
|
Rituxan Concentration
1 year
|
.03 ug/ml
Interval 0.0 to 0.6
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Complete Remission (CR): Imaging studies (Xray, CT, MRI) (nodes, liver, and spleen): Normal Peripheral blood by flow cytometry: No clonal lymphocytes Bone marrow by morphology: No nodules; or if present, nodules are free from CLL cells by immunohistochemistry Duration: ≥2 months CR with minimal residual disease Peripheral blood or bone marrow by flow cytometry: \>0 - \<1 CLL cells/1000 leukocytes (0.1%) Partial Remission (PR): Both criteria: Absolute lymphocyte count in peripheral blood: ≥50% decrease Physical exam/Imaging studies (nodes, liver, and/or spleen): ≥50% decrease Duration: ≥2 months
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=52 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate)
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Number of patients with PK sample testing. 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.
Number of participants without progressive disease and surviving at one year. Participants with FCgammaRIIIa receptor vs participants without FCgammaRIIIa receptor.
Outcome measures
| Measure |
Treatment (Chemotherapy and Rituximab Followed by HCT)
n=32 Participants
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
|
Treatment (Chemotherapy Followed by HCT)
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|---|
|
Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
Surviving participants w/ FCgammaRIIIa receptor
|
2 Participants
|
—
|
|
Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
Surviving participants w/o FCgammaRIIIa receptor
|
21 Participants
|
—
|
|
Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
w/ FCgammaRIIIa receptor w/o progressive disease
|
2 Participants
|
—
|
|
Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
w/o FCgammaRIIIa receptor w/o progressive disease
|
19 Participants
|
—
|
Adverse Events
Treatment
Serious events: 4 serious events
Other events: 22 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Treatment
n=52 participants at risk
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|
|
Renal and urinary disorders
Thrombotic microangiopathy, secondary to cyclosporine, resulting in renal failure requiring dialysis
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Immune system disorders
Death related to grade 4 GVHD
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Infections and infestations
Death-septic shock related to acute GVHD
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
Other adverse events
| Measure |
Treatment
n=52 participants at risk
Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.
Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.
Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation:
|
|---|---|
|
Cardiac disorders
Volume overload likely precipitating hypoxia and heart failure
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Chest CT show filling defect that consistent with pulmonary embolism
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Syncopal episode with neurological exam and head CT unremarkable
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Decrease in LVEF from 55% to 24% due to volume overload
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Sharp left sided chest pain
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Cardiac disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Investigations
Weight gain associated with pleural effusion
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Investigations
Increased bilirubin
|
13.5%
7/52 • Number of events 7 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.7%
4/52 • Number of events 7 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Infections and infestations
Infection (Bacterial & Fungal)
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Nervous system disorders
Syncopal episode
|
3.8%
2/52 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
4/52 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Investigations
Creatinine increased
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
|
Infections and infestations
Systemic inflammatory response syndrome (SIRS)
|
1.9%
1/52 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Historical controls were utilized for comparison
|
Additional Information
Dr. Mohamed Sorror
Fred Hutchinson Cancer Research Center
Phone: 206-667-6298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place